BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLECT CRANIAL NAVIGATION SOFTWARE

    MDR report key: 4925256 · Received July 20, 2015

    Report

    Report Number
    0001811755-2015-02621
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K062640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED EVENT, THE 6000-651-000 WAS CORRECTED TO BE THE PRIMARY DEVICE, AND THE 7700-300-000 IS NOW LISTED AS CONCOMITANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE HEALTHCARE FACILITY, ACCURACY WAS INSUFFICIENT AFTER INITIAL MASK REGISTRATION. IT WAS REPORTED THAT THERE WAS A 30 MINUTE DELAY DURING THE SURGERY. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE HEALTHCARE FACILITY, ACCURACY WAS INSUFFICIENT AFTER INITIAL MASK REGISTRATION. IT WAS REPORTED THAT THERE WAS A 30 MINUTE DELAY DURING THE SURGERY. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469451 INTELLECT CRANIAL NAVIGATION SOFTWARE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1